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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05237310
Other study ID # G-EYE 15076
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2022
Est. completion date September 2022

Study information

Verified date February 2022
Source Smart Medical Systems Ltd.
Contact Ralf Kiesslich, Prof.
Phone +49 611 43-9002
Email Ralf.Kiesslich@helios-gesundheit.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.


Description:

The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria


Recruitment information / eligibility

Status Recruiting
Enrollment 372
Est. completion date September 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Screening and surveillance population for Adenoma and CRC. 2. Subjects age is at least 18 years 3. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of hereditary polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with prior colonic surgery (exclusion appendectomy) 6. Subjects with a history of radiation therapy to abdomen or pelvis; 7. Pregnant or lactating female subjects; 8. Subjects who are currently enrolled in another clinical investigation. 9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 11. Any patient condition deemed too risky for the study by the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Standard Colonoscopy
Standard Colonoscopy using a standard Fujifilm colonoscope
G-EYE Colonoscopy
G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
CAD-EYE
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence

Locations

Country Name City State
Germany Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Wiesbaden

Sponsors (2)

Lead Sponsor Collaborator
Smart Medical Systems Ltd. Fujifilm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Additional Adenoma Detection Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy Upon histology results (up to 30 days)
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